Bioequivalence study of two oral formulations of clarithromycin in human male subjects

Pak J Pharm Sci. 2011 Jan;24(1):43-6.

Abstract

To assess the bioequivalence of tablets formulations of Clarithromycin 500 mg each of test and reference products. A single post oral dose of each formulation was given to 14 male healthy volunteers. The study was conducted phase 1, open-label, randomized, complete two-way crossover designed with 7 days wash out period. The plasma concentration of Clarithromycin was quantified by validated microbiological assay method. The precision of the method was evaluated using calibrated 14-hydroxyClarithromycin concentration was detected semi quantitatively as equivalent of Clarithromycin/ml. The peak plasma concentrations of (3.63±0.80 ug/ml) and (3.31±0.35 ug/ml) was attained in about 1.42 hours and 1.49 hours for both test and reference Clarithromycin tablets respectively. The mean±SD values for total area under the curve (AUC) were 22.07±4.90 and 20.16±2.35 h.mg/L for both test and reference tablets respectively. This study indicated that the differences in all the bioequivalence parameters for test and reference Clarithromycin formulations are statistically non-significant; hence both formulations are considered bioequivalent.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Anti-Bacterial Agents / chemistry
  • Anti-Bacterial Agents / pharmacokinetics
  • Anti-Bacterial Agents / pharmacology*
  • Area Under Curve
  • Biological Availability
  • Chemistry, Pharmaceutical
  • Clarithromycin / chemistry
  • Clarithromycin / pharmacokinetics
  • Clarithromycin / pharmacology*
  • Cross-Over Studies
  • Diffusion
  • Double-Blind Method
  • Haemophilus influenzae / drug effects
  • Half-Life
  • Humans
  • Male
  • Microbial Sensitivity Tests
  • Tablets
  • Therapeutic Equivalency
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Tablets
  • Clarithromycin